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The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France - A Randomised Controlled Trial.
Sponsor: Hedia ApS
Summary
The goal of this randomized controlled study is to assess the clinical performance and safety of Hedia Diabetes Assistant in adults with type 1 diabetes and suboptimal glycemic control in France. The main question to answer is: \- Does Hedia Diabetes Assistant improve glycemic control? Researchers will compare Hedia Diabetes Assistant in addition to standard treatment to standard treatment alone to see if Hedia Diabetes Assistant can improve glycemic control. Subjects will: * Use Hedia Diabetes Assistant in addition to their standard treatment or only use standard treatment for 6 months. * Visit the clinic once when they are included into the study and will otherwise be followed remotely. * Fill out questionnaires when they are included and after 6 months.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2025-03-17
Completion Date
2026-05
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Hedia Diabetes Assistant
Hedia Diabetes Assistant is an insulin bolus calculator app designed to calculate an insulin bolus dose recommendation for people with type 1 or type 2 diabetes on rapid-acting insulin treatment.
Locations (6)
Centre Hospitalier Universitaire d'Angers
Angers, France
Hospices Civils de Lyon
Lyon, France
Centre hospitalier universitaire de Nantes
Nantes, France
Centre hospitalier universitaire de Nîmes
Nîmes, France
Hôpital Bichat - Claude-Bernard
Paris, France
Centre hospitalier universitaire de Poitiers
Poitiers, France